(Mis)informed Consent

Over the years, the practice of medicine has become less of an art, and more a process of crossing T’s and dotting I’s. “Treating the chart” has become, in many ways, more important than treating the patient, and it seems that the pen—or, rather, the electronic medical record—has emerged as a more valuable tool than the stethoscope or reflex hammer.

For psychiatrists, one of the pesky little details of any office visit is obtaining “informed consent.” Most commonly, this is the document—signed by the patient—stating that he/she has been fully informed of the reason they’re being prescribed a medication, the potential risks of taking said medication, and any possible alternatives. Most private insurers and hospitals, and all Medicaid programs, require this documentation in the charts of patients seeing mental health specialists, and (at least in my experience) these documents are frequently sought in chart audits.

What do I mean by “pesky”? Put briefly, the process of obtaining informed consent can be time-consuming, and some doctors worry that it might actually interfere with treatment. In a 2004 survey, for instance, 44% of psychiatrists reported that “informed consent … increases patients’ anxiety.” With respect to antipsychotics, nearly 20% of psychiatrists in the same study admitted “it is good practice to withhold information about tardive dyskinesia from some patients.” As a result, patients are often poorly informed about the meds they take. In a 2001 study of psychiatric inpatients in Scotland, fewer than half knew the reason they were receiving medication, the side effects of those medications, or even remembered getting an explanation from staff. (But, according to the survey, far more than half were “happy to take all medications”!!)

I was recently asked for some suggestions on how to improve the medication-consent process in my outpatient clinic. I must admit, the current process is atrocious. Our forms are 10+ years old, with general descriptions of each class of medication (and, of course, they lack any drug introduced in the last decade); and they have that “photocopy of a photocopy” appearance, with faded margins and text at a crooked angle. But hey, no big deal—they’re just papers to sign and stick in the chart, basically. In the community clinic where I work part-time, the process is even more rudimentary: we have one generic form with no drug names or descriptions; the front-desk staff asks each patient to sign the form before each visit, and afterward I simply write in the name of the medication(s) I’ve prescribed.

In thinking of ways to improve the process, I’ve come to realize that it may provide an opportunity for some meaningful change in our treatment approach.

First of all, there’s no excuse for not describing the potential adverse effects of the drugs we use, but we must be cautious not to trivialize this process. Most psychiatrists I know, for example, have a readymade “speech” about the potential for rash with Lamictal, or weight gain with Zyprexa, or sedation with Seroquel. (See this post at Shrink Rap—and its comments—for more on this perspective.) But if the patient hears this as just a “speech,” it’s less likely to be meaningful, just like the pre-flight safety lectures you hear on airplanes. I advise my students and residents to pretend they’re prescribing to their spouse, parent, or child, and give all the information they would want to hear about each new drug. (This includes how to stop the medication, too.)

Second, just as important as the potential adverse effects, I believe that patients need to hear more specific explanations of how the drug might actually provide some benefit. All too often we give a feeble explanation like “this Prozac should make you feel better in a few weeks” or ” Valium might calm your nerves a bit” or “since you haven’t responded to your antidepressant, here’s some Abilify to help it along.” We owe it to our patients (and to ourselves) to provide more detailed explanations. To be sure, most patients don’t need to hear a molecular mechanism, complete with pKa values or details of CYP450 metabolism, but we ought to have this information in our heads, and we must know how we’re using this information to treat the patient in front of us. When a patient asks how an antipsychotic might help their depression, or why an anticonvulsant might help stabilize their mood, we must give an answer. (And if no good answer is possible, we need to rethink our treatment plan.)

Third, it is equally important to discuss treatment options with a patient. When patients ask “is there anything else I can do or take?” the ensuing discussion might extend the appointment by a few minutes, but it always leads to a more collaborative dialogue (unless, of course, the patient is fishing for a Xanax prescription or a month’s supply of Seroquel to sell for cash). A discussion of alternatives often gives an indication of what the patient wants, what the patient values, and how we can best promote the patient’s recovery.

Finally, the informed consent process really should be extended to non-psychiatrists who prescribe these agents. Primary-care docs routinely prescribe antidepressants, benzodiazepines, psychostimulants, and mood stabilizers (and, of course, my personal favorite, “Seroquel for sleep”), without a discussion of risks, benefits, and alternatives, or (in most cases) a signed consent form. Heck, even gastroenterologists prescribe Reglan, which is as likely to cause tardive dyskinesia as many of the antipsychotics we use in psychiatry, and pain specialists are fond of Cymbalta (an SNRI with some potentially nasty withdrawal effects) for “chronic pain.” These providers should recognize the potential risks (and mechanisms) of psychotropics, just as psychiatrists do, and share them with their patients.

So even though we might look at obtaining informed consent as a “necessary evil,” we should instead look at it as a way to enhance treatment. If nothing else, this would force us to think about what we do and why we do it. It would enable us to honestly evaluate the true benefits and risks of what we prescribe, and maybe steer us in a different—and healthier—direction.

…This is a really scary article for me. I always knew psychiatrists were terrible at explaining the risks associated with the medicines they prescribe (personal experience), but I didn’t realize that was intentional. These medications have really serious side effects. I figured doctors were just bent on getting through the appointment in 15 minutes or less. Patients will fall apart on these drugs. Especially kids. Explaining the meds should be done thoroughly. No matter how much the doctor thinks it might scare away the patient.

Also, I know the public is more informed, but some people simply cannot take these medications. And when others do not realize how terrible the side effects can be, they think their bipolar cousin is not on meds because he just loves those manic highs or the ADHD kid isn’t on meds because he is defiant. And that is not always the case. I don’t think your average person stops a med that is actually helping. I think they stop because the med makes them feel like they want to kill themselves or some other serious reason.

Exactly, Mara!! I get horror reactions and told that I just don’t “want” to take meds, when I had no end of problems with them and they just made me worse, for many years. My treating professionals and family are glad I gave up with meds and just do my best to limp along with therapy alone. Folks think you are a psychiatry denier when you point out that the meds are no cure all.

Interesting. I never knew that psychiatry had even a glimmer of interest in informed consent. I know I never got it regarding psychiatric drugs from any psychiatrist or other doctor (other than my present doctor, who truly is exceptional).

Misinforming in order to bend the patient to the doctor’s will is the first step in infantiilizing and disenfranchising the patient. This toxic relationship can’t be good for the patient’s self-respect or overall mental health.

When it comes to psychiatric drugs, I wonder what forces cause doctors to make this compromise in ethical behavior? I guess they don’t think very highly of people who ask for or fit a psychiatric diagnosis.

With hindsight I would gladly accept the huge treatment progress I was able to achieve in part due to the stability provided by the multiple years of anti-psychotics in the beginning. Even though I traded it for a 15 years too early diabetes dx and 50lbs of weight I cant manage to keep off.

I dont think my earlier, less stable, less introspective self would have made the trade. At eighteen I had no perspective on the potential gains available to me. I didnt know it was possible to learn enough skills to help myself to a point that doenst need the heavy duty meds. I also didnt know the cost (partly because at the time even my doc didnt clearly know the cost)

I do find it interesting that the docs prescribing my all too frequent rounds of predisone dont seem to have as much conflict or problem convincing patients it is needed even though it plays hell with the blood sugar, blood pressure and adds 15lbs for each new round. I guess not breathing is a better motivator.

Informed consent?
Are you kidding me?
How many psychiatrists actually use informed consent?

If your profession went into detail of the risks involved in “treatment”… REALLY explained what these drugs do…

And if your profession explained that there were many non-drug options that work… options that are safer and more effective than your “treatment,” your profession would find itself where 10 percent of your fellow Americans are today… Unemployed!

FWIW, it’s a problem in Pediatrics as well. There is no informed consent process whatsoever when I prescribe Amoxicillin for acute lobar pneumonia. For that matter, there’s no informed consent for anything except HIV testing.

If we were required to obtain informed consent, my colleagues and I would have to discuss harms. Good luck with that.

In the age of internet, it’s so silly that a psychiatrist wouldn’t be up front with their client on side effects. When psychiatrists in the past haven’t told me the side effects, I’ve run home and read them myself. Doesn’t sound so bad, right? Except that sometimes I’d get home and scare the everliving piss out of myself and refuse to take what I’d been prescribed, so when I showed up at my appointment a month from then my psychiatrist would end up all pissed off and tension would build and, well, I’m not seeing him anymore. Not telling me what those godawful side effects were pretty much ruined any chance of us being able to work together, I couldn’t trust him and I didn’t feel like he was working *with* me.

Had he been up front about the side effects, and discussed with me how we would deal with said side effects instead of being all ignorant about it, I would have been able to express my fears and work out a plan with him before leaving the office. If for some reason I still wouldn’t take the medication he was wanting to prescribe, we could have discussed my reasons and considered other options right then, instead of a month down the road.

Now I have a new psychiatrist who, if there’s a high chance of really bad side effects tells me, otherwise letting me know there may be some minor side effects that I should consider looking up at home. With every med change he says if it’s unbearable to go back to my previous dosage, or if it’s a new med to simply stop taking it. He leaves a part of the decision up to me, always asking my opinion before pulling out the prescription pad. He could practically prescribe me anything under the sun and, with his honesty and willingness to work with me to ensure things don’t go wrong, I’m very likely to give it a try. This is how psychiatrists should work when possible, with the client. If you want to work with puppets limit yourself to inpatient psychiatry, but us outpatients want and need to have a say in our treatment.

I was never once warned not to get pregnant while taking these pills and the ONLY side effect I was warned about with antipsychotics was tardive dyskenesia. With lithium, I was warned about drinking enough water and getting blood tests, but nothing about kidney damage. Antidepressants? I got no warnings at all. Lamictal, I was warned about the rash. Perhaps doctors assumed I would look it up on the internet, but I had no internet for 10 years – just got it a few years back. And by reading on the internet, it’s hard to know which are common side effects and which are very unlikely to happen.

I had assumed it was the 15 min med check at fault, but perhaps the doctors were deliberately covering up. I have suspected that for a long time, in fact. I don’t think the doctors’ goals for treatment were the same as mine, and they would do almost anything to have me take these pills that just made things worse (but they were well-meaning docs who were trying to help, just too caught up in their pills to realize that for some people, the side effects make life worse). Some of my previous docs took tens of thousands from drug companies, I have discovered, so maybe that blinded them to the harm the pills were causing.

This is an important subject, not limited to psychiatry (as Rob alluded to above). I wonder if a tad ‘o technology might not help here.

There are several reliable open access drug and supplement patient databases which are useful to maintain current and prior medication inventories. (I’m using medications as a broad term to encompass both prescription/OTC and supplements). I use Drugs.com, which allows for med lookup, includes plain English descriptions, indications, effects, adverse reactions, drug/food-drug interactions and instructions on how to take medications safely. The user has control over what to list, updates and deletions. There are also free text options to describe individual needs, reactions, situations, etc.

I can email or print the list for personal use as well as for sharing with my pharmacist and physicians. I have stayed with this product because my physician’s medical system online medication database doesn’t allow for supplements!?!?! Never have any of my physicians asked about them, either (and this is a healthcare system which is considered a national leader).

So what I propose is physician’s offices/clinics/ACOs/discharge planners, etc. using a staff support person to establish a user account for every patient seen and in collaboration with them, creating and maintaining medication lists. On start-up, every patient to be enrolled might be asked to arrive for a scheduled visit 15-30 minutes early to establish the user account, be taught to use the database and enter the current meds used. Prior to each vs., patients should be reminded to update their med lists and bring questions about them to the vs. Physicians/treaters can then pull up the records, ask about discrepancies/new meds/reactions, etc.

Even though I offered access to my account to every physician I saw, no one was interested in having it. However, they did accept my printed current med lists. (None of the supplements I took ever made it into the EHR).

It seems to me that using tools, such as this one, would facilitate better time utilization, allow for more patient control and empowerment, would promote medication administration adherence, and would strengthen the physician/patient relationship. These tools are available in multiple languages, too.

Giving patients handouts on individual drugs is a start, but that doesn’t tell the patient jack about the risks of mixing multiple drugs together. I can look up effexor and see what the risks are, but I needed the psychiatrist to discuss the risks of his mixing Effexor @ x dose + Wellbutrin @ x dose + lamictal @ x dose + Seroquel @ x for sleep. What does mixing all of that together do to me? What are the risks of that cocktail? I’m not a pharmacologist and it’s not easy to determine the risks of all those drugs mixed together, or the most common side effects seen so I would know what to look for.

As others have pointed out, the problem isn’t limited to psychiatrists. I don’t even begin to know how a physician educates an elderly patient on the risk of side effects when they’re on a list of meds a mile long. I guess I expected more from my psychiatrist regarding education because I sat there with him for an hour, and they’re supposed to be good at the communication thing. He had a little more time to work on patient education than a visit to an internal med doc.

I didn’t realize at the time how dangerous it was to cold turkey off all those drugs, or throw in a particular OTC cold medication when I was under the weather. I learned the hard way that I was going to have to educate myself, or I would pay for it.

I too have the brain zaps-they suck! I have taken both Effexor and now Cymbalta, the problem is I am not trying to wean off. I get the zaps if I miss taking my medication by an hour or so and the tinnitus and nausea are difficult to deal with while teaching 5th graders. I thought I was nuts too or that there was something major wrong with my brain,,,,nope just doctor prescribed medication…yeah us!

I can’t imagine trying to get off this crap, but I know I have to or something else will happen even worst. I do understand what we are all going through is a difficult situation, so why doesn’t our doctors explain in detail what will happen if they know? It is frustrating when you trust your doctor to do what is best for you since they are the ones trained to care for us. We deserve to be told about the medication they they prescribe us so we can then decide to take the risk or not.

Steve Balt

All posts, unless otherwise noted, are written by Steve Balt, MD, current Editor-in-Chief of The Carlat Psychiatry Report (TCPR). TCPR is a monthly continuing education newsletter for psychiatrists and other mental health professionals with a focus on practical tips, clinical pearls, and reviews of research with the promise of no pharmaceutical or device industry bias. Read more about Dr. Balt on his About Me page.